Mikart
Mikart specializes in the development, manufacturing, and packaging of solid-dose and liquid-oral dose products.
Mikart specializes in the development, manufacturing, and packaging of solid-dose and liquid-oral dose products. The company’s services include formulation development; analytical, manufacturing, packaging, and regulatory services; and complete project management. Mikart offers clients more than 40 years of experience, a responsive working relationship, and the ability to take products from formulation development through full-scale commercial production.
Mikart, Inc.
www.mikart.com
tel. 404.351.4510
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
